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Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy

19 de enero de 2015 actualizado por: Novartis Pharmaceuticals

Presentation of Renal Function in Liver Transplant Recipients With Certican Therapy: PROTECT Study A Twelve-month, Multicenter, Randomized, Open-label Study of Safety, Tolerability and Efficacy of Certican-based Regimen Versus Calcineurin Inhibitor-based Regimen in de Novo Liver Transplant Recipients

The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to continuation of CNI-based treatment.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

276

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 13353
        • Novartis Investigative Site
      • Essen, Alemania, 45147
        • Novartis Investigative Site
      • Frankfurt, Alemania, 60590
        • Novartis Investigative Site
      • Hamburg, Alemania, 20246
        • Novartis Investigative Site
      • Hannover, Alemania, 30625
        • Novartis Investigative Site
      • Heidelberg, Alemania, 69120
        • Novartis Investigative Site
      • Jena, Alemania, 07740
        • Novartis Investigative Site
      • Muenster, Alemania, 48149
        • Novartis Investigative Site
      • Regensburg, Alemania, 93053
        • Novartis Investigative Site
      • Tübingen, Alemania, 72076
        • Novartis Investigative Site
  • Austria
      • Innsbruck, Austria, A-6020
        • Novartis Investigative Site
      • Wien, Austria, A-1090
        • Novartis Investigative Site
  • Países Bajos
      • Groningen, Países Bajos, 9713 GZ
        • Novartis Investigative Site
      • Rotterdam, Países Bajos, 3015 CE
        • Novartis Investigative Site
  • Suiza
      • Genève, Suiza, 1211
        • Novartis Investigative Site
      • Zurich, Suiza, 8091
        • Novartis Investigative Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Males or females 18 - 70 years old
  • Liver transplant recipient (living or deceased donor)
  • Patients in whom an allograft biopsy will not be contraindicated

Exclusion Criteria:

  • Recipients of multiple solid organ transplants or patients that have already received a transplant in the past
  • HCV positive patients who need an active anti-viral treatment (HCV- positive patients without active antiviral treatment are allowed)
  • HIV positive patients
  • Patients who are breast feeding
  • Patients with a current severe systemic infection
  • Presence of any hypersensitivity to drugs similar to Certican® (e.g. macrolides)
  • Preexisting (i.e. not related to CNI-damage) renal dysfunction that, according to the judgment of the investigator, will not significantly improve after transplantation (i.e., for example, patients that are expected to have a cGFR below 50ml/min at 4 weeks post transplantation)
  • Patients that have received Simulect prior to this study.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Everolimus
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Droga: basiliximab
All patients who met the eligibility criteria were treated with 2 doses of basiliximab on Day 0 (transplantation) and Day 4.
Otros nombres:
  • simulect
Droga: CNI
Patients who met the screening eligibility received CNI-based immunosuppressive therapy for 1 month. Then at week 4 (or week 8 at maximum), patients randomized to the CNI arm continued on CNI-based immunosuppressive therapy.
Comparador activo: Calcineurin Inhibitor (CNI)
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Droga: basiliximab
All patients who met the eligibility criteria were treated with 2 doses of basiliximab on Day 0 (transplantation) and Day 4.
Otros nombres:
  • simulect
Droga: CNI
Patients who met the screening eligibility received CNI-based immunosuppressive therapy for 1 month. Then at week 4 (or week 8 at maximum), patients randomized to the CNI arm continued on CNI-based immunosuppressive therapy.
Droga: everolimus
Start dose of everolimus was 1.5 mg in the morning followed by 1.5 mg in the evening. After one week, the dose was adjusted to achieve trough levels between 5-12 ng/mL. Once trough levels were above 5ng/mL, the CNI dose was reduced to 70%. At week 8 post-baseline (latest at week 16 post baseline), CNI was completely discontinued. For patients receiving Ciclosporin A (CiA) as CNI, the everolimus dosage was adjusted to achieve a trough level of 8-12 ng/mL, prior to discontinuation of CiA. After discontinuation of CNI, everolimus was maintained at a trough level of 5-12 ng/mL.
Otros nombres:
  • certicar

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Calculated Glomerular Filtration Rate (cGFR)
Periodo de tiempo: Month 11
This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.
Month 11

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of Efficacy Failure
Periodo de tiempo: Month 11
Efficacy failure was defined as the composite endpoint of biopsy-proven acute rejection (BPAR), graft loss, death, lost to follow-up (from any reason), whichever occurred first. Incidence of efficacy failure was estimated using crude rate estimation (relative frequency).
Month 11
Incidence of the Need for a Change in the Immunosuppressive Regimen
Periodo de tiempo: Month 11
The incidence of any changes in the immunosuppressive regimen other than allowed in the study protocol (for example, introduction of Mycophenolic acid (MPA) or sirolimus) was estimated using crude rate estimation (relative frequency).
Month 11
Incidence of Renal Deterioration
Periodo de tiempo: Baseline, Month 11
Renal deterioration was defined as a decrease by ≥25% in the cGFR compared to baseline and confirmed by one consecutive measurement. The analysis of this outcome measure was omitted because of missing relevance.
Baseline, Month 11
Renal Function (cGFR)
Periodo de tiempo: Month 5
This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.
Month 5
Incidence of Treated BPAR
Periodo de tiempo: Month 11
The incidence of treated BPAR was estimated using crude rate estimation (relative frequency).
Month 11
Patient and Graft Survival
Periodo de tiempo: Month 11
Patient survival was defined as the time from date of randomization to date of death from any cause. If a patient was not known to have died, patient survival was censored as the date of last contact. Graft survival was defined as the time from the date of randomization to the date of graft loss. If a patient was not known to suffer from a graft loss or died without graft loss, time to graft loss was censored with date of last contact or date of death, respectively. Patient and graft survival were analyzed using the Kaplan Meier method.
Month 11
Hepatitis C Virus (HCV) Replication in HCV-positive Patients
Periodo de tiempo: Baseline, Month 5
HCV ribonucleic acid (RNA) was measured by real time reverse transcriptase polymerase chain reaction (PCR; copies per mL).
Baseline, Month 5
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Periodo de tiempo: From randomization to Month 11
Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.
From randomization to Month 11
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Periodo de tiempo: Month 12 to Month 59 post-baseline
Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.
Month 12 to Month 59 post-baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis Pharmaceuticals

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2006

Finalización primaria (Actual)

1 de enero de 2013

Finalización del estudio (Actual)

1 de enero de 2013

Fechas de registro del estudio

Enviado por primera vez

15 de septiembre de 2006

Primero enviado que cumplió con los criterios de control de calidad

18 de septiembre de 2006

Publicado por primera vez (Estimar)

19 de septiembre de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

6 de febrero de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

19 de enero de 2015

Última verificación

1 de enero de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CRAD001HDE10
  • 2005-002920-32

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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